MATERIAL SAFETY DATA SHEET

Transcription

1 MATERIAL SAFETY DATA SHEET 1. Product and Company Identification Material name Version # 01 Revision date CAS # OPTIRAY IOVERSOL INJECTION Mixture Synonym(s) OPTIRAY 160 Ioversol Injection 34% * OPTIRAY 240 Ioversol Injection 51% * OPTIRAY 300 Ioversol Injection 64% * OPTIRAY 320 Ioversol Injection 68% * OPTIRAY 350 Ioversol Injection 74% * N,N'-bis(2,3-dihydroxypropyl)-5-[N-(2-hydroxyethyl-gl ycolamido]-2,4,6-triiodoisophthalamide Manufacturer information Mallinckrodt 675 McDonnell Blvd. Hazelwood, MO United States 24 Hour Emergency Chemtrec Customer Service Hazards Identification Emergency overview OSHA regulatory status Potential health effects Routes of exposure Eyes Skin Inhalation Ingestion Chronic effects Potential environmental effects The hazard warnings associated with this product are based on the individual ingredients included in the finished dosage form of the pharmaceutical product. The supplied package insert (approved labeling) provides the necessary drug safety information. Avoid any exposure. Handle in accordance with good industrial hygiene and safety practice. As per 29 CFR (b)(5)(iii), any food, food additive, color additive, drug, cosmetic, or medical or veterinary device or product, including materials intended for use as ingredients in such products (e.g. flavors and fragrances), as such terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and regulations issued under that Act, when they are subject to the labeling requirements under that Act by the Food and Drug Administration are exempted from the requirements of the Hazard Communication Standard. All Mallinckrodt finished products are labeled in compliance with the requirements of the Food and Drug Administration (FDA) and must be used in the prescribed manner. Each package of the finished pharmaceutical product is supplied with a package insert (approved labeling) which provides necessary drug safety information. Ingestion. Skin contact. Eye contact. Direct contact may irritate. The hazardous properties of the product are considered limited. May cause minor irritation on skin contact. Health injuries are not known or expected under normal use. Ingestion of large amounts may produce gastrointestinal disturbances including irritation, nausea, and diarrhea. Allergic reactions are possible. ne known. Ecological injuries are not known or expected under normal use. 3. Composition / Information on Ingredients n-hazardous components CAS # Percent IOVERSOL EDETATE CALCIUM DISODIUM <1 1 / 5

2 TRIS (HYDROXYMETHYL) AMINOMETHANE Other components below reportable levels < First Aid Measures First aid procedures Eye contact Skin contact Inhalation Ingestion General advice 5. Fire Fighting Measures Flammable properties Extinguishing media Suitable extinguishing media Fire fighting equipment/instructions Immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation develops and persists. Rinse skin with water/shower. Get medical attention if irritation develops and persists. t likely, due to the form of the product. If ingestion of a large amount does occur, call a poison control center immediately. Do not induce vomiting without advice from poison control center. Rinse mouth. If you feel unwell, seek medical advice (show the label where possible). t flammable by OSHA criteria. Use any media suitable for the surrounding fires. As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear. 6. Accidental Release Measures Personal precautions Environmental precautions Methods for cleaning up special precautions are necessary beyond normal good hygiene practices. See Section 8 of the MSDS for additional personal protection advice when handling this product. special environmental precautions required. Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Large Spills: Use a non-combustible material like vermiculite, sand or earth to soak up the product and place into a container for later disposal. Following product recovery, flush area with water. Clean surface thoroughly to remove residual contamination. For waste disposal, see section 13 of the MSDS. 7. Handling and Storage Handling Storage Handle and open container with care. Do not handle until all safety precautions have been read and understood. Avoid contact with eyes. Avoid contact with skin. Do not ingest. When using, do not eat, drink or smoke. Wash thoroughly after handling. Keep container tightly closed. Keep from freezing. Storage temperature: between 15 C (59 F) and 30 C (86 F). Protect from light. Use care in handling/storage. Store in accordance with local/regional/national/international regulation. 8. Exposure Controls / Personal Protection Engineering controls General ventilation normally adequate. Personal protective equipment Eye / face protection Safety glasses. Provide eyewash station and safety shower. Skin protection Wear appropriate chemical resistant clothing. Wear protective gloves. Respiratory protection personal respiratory protective equipment normally required. General hygiene Handle in accordance with good industrial hygiene and safety practice. considerations 2 / 5

3 9. Physical & Chemical Properties Appearance Clear. Physical state Liquid. Form Liquid. Color Colourless to light yellow. Odor Odorless. Odor threshold t available. ph t available. Vapor pressure 0 hpa estimated Vapor density t available. Boiling point 212 F (100 C) estimated Melting point/freezing point t available. Solubility (water) Complete Specific gravity Relative density t available. Flash point t available. Flammability limits in air, upper, t available. % by volume Flammability limits in air, lower, t available. % by volume Auto-ignition temperature t available. VOC % estimated Percent volatile % estimated 10. Chemical Stability & Reactivity Information Chemical stability Material is stable under normal conditions. Instability caused by exposure to light. Conditions to avoid ne under normal conditions. Incompatible materials t available. Hazardous decomposition Toxic gas. Nitrogen oxides (NOx). Iodine. products 11. Toxicological Information Toxicological data Product OPTIRAY IOVERSOL INJECTION (Mixture) Components Test Results Acute Other LD50 Rat: 15 g/kg Intravenous (68% Injection) Test Results EDETATE CALCIUM DISODIUM ( ) TRIS (HYDROXYMETHYL) AMINOMETHANE ( ) Sensitization Local effects Chronic effects Carcinogenicity t a skin sensitizer. Acute Oral LD50 Rat: 10 g/kg Acute Oral LD50 Rat: 5900 mg/kg May cause eye irritation. Mild skin irritation. Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea. ne known through occupational exposure. This product is not considered to be a carcinogen by IARC, ACGIH, NTP, or OSHA. 12. Ecological Information Ecotoxicity Environmental effects This product has no known eco-toxicological effects. t classified as an environmental hazard. Ecological injuries are not known or expected under normal use. 3 / 5

4 Persistence and degradability data is available on the degradability of this product. 13. Disposal Considerations Disposal instructions 14. Transport Information DOT t regulated as dangerous goods. IATA t regulated as dangerous goods. IMDG t regulated as dangerous goods. 15. Regulatory Information US federal regulations This product, in its present state, when discarded or disposed of, is not a hazardous waste according to Federal regulations (40 CFR (b)(4)). Under RCRA, it is the responsibility of the user of the product to determine, at the time of disposal, whether the product meets RCRA criteria for hazardous waste. Dispose in accordance with all applicable regulations. Disposal recommendations are based on uncontaminated material. This material is not subject to the Federal OSHA Hazard Communication Standard 29 CFR (b)(5)(iii). TSCA exempt status. Drug Enforcement Administration (DEA). List 2, Essential Chemicals (21 CFR (b) and (f)(2) t regulated DEA Essential Chemical Code Number t regulated Drug Enforcement Administration (DEA). List 1 & 2 Exempt Chemical Mixtures (21 CFR (c)) t regulated DEA Exempt Chemical Mixtures Code Number t regulated CERCLA (Superfund) reportable quantity ne Superfund Amendments and Reauthorization Act of 1986 (SARA) Hazard categories Section 302 extremely hazardous substance Section 311 hazardous chemical Inventory status Country(s) or region Australia Canada Canada China Europe Europe Japan Immediate Hazard - Delayed Hazard - Fire Hazard - Pressure Hazard - Reactivity Hazard - Inventory name Australian Inventory of Chemical Substances (AICS) Domestic Substances List (DSL) n-domestic Substances List (NDSL) Inventory of Existing Chemical Substances in China (IECSC) European Inventory of Existing Commercial Chemical Substances (EINECS) European List of tified Chemical Substances (ELINCS) Inventory of Existing and New Chemical Substances (ENCS) On inventory (yes yes/no no)* 4 / 5

5 Country(s) or region Korea New Zealand Philippines United States & Puerto Rico Inventory name Existing Chemicals List (ECL) New Zealand Inventory Philippine Inventory of Chemicals and Chemical Substances (PICCS) Toxic Substances Control Act (TSCA) Inventory On inventory (yes yes/no no)* *A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s) State regulations 16. Labeling Info Label Hazard Warning Label Precautions - Label First Aid Other Information Recommended use California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): This material is not known to contain any chemicals currently listed as carcinogens or reproductive toxins. Mallinckrodt finished products are labeled in compliance with the requirements of the Food and Drug Administration (FDA) and must be used in the prescribed manner. Each package of the finished pharmaceutical product is supplied with a package insert (approved labeling) which provides necessary drug safety information. Diagnostic imaging agent. NFPA ratings Health: 0 Flammability: 0 Instability: 0 Disclaimer Issue date Mallinckrodt (D/B/A Covidien) provides the information contained herein in good faith but makes no representation as to its comprehensiveness or accuracy. This document is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose. MALLINCKRODT MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE PRODUCT TO WHICH THE INFORMATION REFERS. ACCORDINGLY, MALLINCKRODT WILL NOT BE RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF OR RELIANCE UPON THIS INFORMATION. 5 / 5